Merck KGaA Pins Cladribine Hopes On Ongoing Studies After "Complete Response" Letter
This article was originally published in Pharmaceutical Approvals Monthly
Merck KGaA is hoping data from already completed and ongoing studies will satisfy FDA's need to better understand the risk-benefit profile for its oral multiple sclerosis therapy cladribine, after the agency issued a "complete response" March 2.
You may also be interested in...
Millipore acquisition boosts 2010 results for Germany's Merck, but pharma strategy remains unclear.
European regulators rebuff Fampyra and Movectro, but approve Gilenya.
Surprise rejection hits German drugmaker hard and casts doubt over FDA approval.